Package Insert: Information for the User

cinfamucol acetilcisteína forte 600 mg powder for oral solution

acetilcisteína

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Acetilcisteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it, and facilitating its elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating its expulsion, in catarrhal and influenza-like processes, in adults.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take cinfamucol acetilcisteína forte

• If you are allergic to acetylcysteine and its derivatives, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamucol acetilcisteína forte.

If you are asthmatic or have a severe respiratory disease, you must consult with your doctor before taking this medication.

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.

If you experience stomach discomfort while taking the medication, you should discontinue treatment and consult your doctor. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

During the first few days of treatment, you may notice an increase in mucus and phlegm, which will decrease over the course of treatment.

Children and adolescents

People under 18 years old cannot take this medication. There are other presentations that are more suitable.

Other medications and cinfamucol acetilcisteína forte

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

The concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not administer concomitantly with cough medications or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking medications that contain minerals such as iron or calcium, or medications with antibiotics (such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate your intake of cinfamucol acetilcisteína forte by at least 2 hours.

It is not recommended to dissolve cinfamucol acetilcisteína forte with other medications.

Taking cinfamucol acetilcisteína forte with food and beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is recommended to avoid its use during pregnancy.

It is recommended to avoid taking it during lactation.

Driving and operating machines

There is no evidence of effects on the ability to drive and operate machines.

cinfamucol acetilcisteína forte contains aspartame

This medication contains 20.00 mg of aspartame in each package.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

cinfamucol acetilcisteína forte contains yellow orange S

This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults (18 years and older)

Administer 1 tablet (600 mg of acetilcisteína). Do not exceed the dose of 1 tablet (600 mg) per day.

Use in children and adolescents

People under 18 years old cannot take this medication.

How to take

cinfamucol acetilcisteína forteis taken orally.

Dissolve the contents of the tablet in a glass of water. It is recommended to drink a large amount of liquid throughout the day.

You should consult a doctor if it worsens or does not improve after 5 days of treatment

If you take more cinfamucol acetilcisteína forte than you should

If you take more cinfamucol acetilcisteína forte than you should you may experience nausea, vomiting, heartburn, stomach pain, diarrhea, or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rare (may affect up to 1 in 100 patients):hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Uncommon (may affect up to 1 in 1,000 patients):drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

Very rare (may affect up to 1 in 10,000 patients):allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, which may be identified in conjunction with the use of another medication.

Unknown frequency (cannot be estimated from available data):facial swelling.

In the event of any skin or mucous membrane alteration, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use,https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of cinfamucol acetilcisteína forte

• The active ingredient is acetilcisteína.Each sachet contains 600 mg of acetilcisteína.
• The other components are: aspartamo (E-951), orange aroma(prepared aromatizers, flavorings, natural flavorings, maltodextrin of corn, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)), yellow-orange colorant S (E-110), manitol (E-421) and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

cinfamucol acetilcisteína forte is presented in the form of sachets with a homogeneous powder of the same color and orange flavor.

Each package contains 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: December2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/